PRECISION XTRA/OPTIUM Adverse Event — Injury (MDR 2954323-2008-00838)
PRECISION XTRA/OPTIUM Adverse Event — Injury (MDR 2954323-2008-00838) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PRECISION XTRA/OPTIUM; Generic name: BLOOD GLUCOSE METER; Manufacturer: ABBOTT DIABETES CARE LIMITED UK.
| Device | PRECISION XTRA/OPTIUM |
|---|---|
| Generic name | BLOOD GLUCOSE METER |
| Manufacturer | ABBOTT DIABETES CARE LIMITED UK |
| Report number | 2954323-2008-00838 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-15 |
| Report source | Consumer |
| Narrative | A CUSTOMER REPORTED RECEIVING AN ERROR 658 ON THE DISPLAY OF THEIR PRECISION XTRA BLOOD GLUCOSE METER, AND COULD NOT PROPERLY OBTAIN A GLUCOSE READING. AS A RESULT, THE CUSTOMER REPORTED FEELING WEAK, FATIGUED, AND THAT HER "THROAT WAS VERY TIGHT." THE CUSTOMER THEN REPORTED THAT ON TWO SEPARATE OCCASIONS WITHIN THE THREE WEEKS PRIOR TO CALLING ADC CUSTOMER SERVICE, EXPERIENCING A LOSS OF CONSCIOU |
| Source | openFDA MAUDE (device adverse events) |
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